- Indication
- Promotion of ectopic bone formation
- RAG rating
- Red
- Document type
- Decision document
- Place
- Hertfordshire and West Essex ICB
- Output type
- Pharmacy / Prescribing
Dibotermin alfa
HERTFORDSHIRE AND WEST ESSEX AREA PRESCRIBING COMMITTEE (HWE APC)
Bone morphogenetic proteins (BMP)
RED
Recommended for restricted prescribing by specialist only
Not recommended for primary care prescribing
Name generic (trade) Dibotermin alfa
What it is Bone morphogenetic proteins
Indication Promotion of ectopic bone formation
Date decision last revised HMMC April 2015 WEMOPB April 2016
Decision status Final
NICE / SMC Guidance SMC restricted recommendation
HWE APC recommendation
Not recommended for primary care prescribing
Recommended for restricted use in secondary/tertiary care for acute tibial fractures with grade IIIB fractures (ie more severe cases)
Dibotermin alfa is recommended as an adjunct to standard care using open fracture reduction and intramedullary nail fixation in patients in whom there is a substantial risk of non-union. It is restricted to patients treated with unreamed intramedullary nails.
Applications for funding should be made on a patient specific funding proforma, produced/agreed by the appropriate host commissioner for the Provider Trust requesting funding.
NOT RECOMMENDED:
- In skeletally immature individuals defined as those who can reasonably be expected to not have fusion of the long bone epiphyses, in other words they are still growing (variant; normally in girls below 16 years and in boys below 19 years, but will require individual confirmation).
- For repeat doses or sequential use of BMPs due to the possible development of antibody production.
- The use of BMP in other conditions not specifically included in this policy which may be commissioned by ICBs, is not supported.
This policy does not cover the use of BMP for specialist services/conditions commissioned by NHS England. e.g. revision of previous spinal surgery. See NHS England policies http://www.england.nhs.uk/
At HMMC, April 2015 and WEMOPB April 2016 the committee agreed to adopt the East of England Priorities Advisory Committee recommendation for bone morphogenetic proteins (dibotermin alfa).
Clinical Effectiveness and safety:
- Evidence summary can be found in appendix 1 of reference 1 given below.
- The FDA issued a warning in July 2008 that use of recombinant human bone morphogenetic protein products in cervical spine fusion had been associated with at least 38 reports of swelling of neck and throat tissue, with resultant compression of the airway or vulnerable neurological structures. Complications were often life-threatening and had required respiratory support and/or tracheotomy in some cases. The use of alternative treatments or enrolment in approved clinical studies was recommended when treating cervical spine problems.
Cost effectiveness
Considered to be cost effective by SMC. Cost effectiveness has only been shown in Gustilo-Anderson Grade IIIB fractures.
Needs of the population
The needs of the population are high for this small group of patients with complex fractures.
Needs of the community
The needs of the community are low as the treatment will affect a small population and treatment has been commissioned previously so no significant change in expenditure is expected.
Policy drivers
Updating existing commissioning policy with new commissioner split of funding responsibility.
Equity
No issues identified.
References
1. The East of England Priorities Advisory Committee Guidance statement, Bone morphogenetic proteins, https://www.prescqipp.info/our-resources/webkits/?filters=pageId-1218&pageNo=1&random=0.10551691258644746login required
2. Scottish Medicines Consortium, dibtotermin alfa, April 2007 https://www.scottishmedicines.org.uk/medicines-advice/dibotermin-alfa-inductos-fullsubmission-36507/
Review date: The recommendation is based upon the evidence available at the time of publication. This recommendation will be reviewed upon request in the light of new evidence becoming available.